BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma

NCT06761911 | Not Yet Recruiting Phase 4

• 1 other identifier: DalianMU
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. The main questions it aims to answer are: To evaluate the efficacy and toxicity of BV-containing regimen in relapsed/refractory CHL patients in China, and to provide reference for the rational and safe use of BV in clinical practice.

Conditions

Hodgkin Lymphoma (Category)

Keywords

Brentuximab Vedotin; Hodgkin lymphoma; refractory recurrence; real world; china

Outcome Measures

Primary Outcomes (2)

• Preliminary Overall Response Rate (ORR)

  Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy.

  Up to 16 cycles (each cycle is 21 days)

• Progression-free survival (PFS)

  Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date.

  From time of study enrollment until first documentation of progressive disease or death from any cause, assessed up to 3 years

Secondary Outcomes (1)

• Safety and tolerability of Brentuximab Vedotin

  1 year

Study Arms (2)

BV monotherapy group

ACTIVE COMPARATOR

It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year.

Drug: Brentuximab Vedotin (Bv)

BV combined treatment group

ACTIVE COMPARATOR

For the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator.

Drug: Brentuximab Vedotin (Bv); Drug: Sintilimab; Drug: Tislelizumab; Drug: Bendamustine

Interventions

Brentuximab Vedotin (Bv) DRUG

1.2mg/kg/2w or 1.8mg/kg/3w

Also known as: BV, Adcetris

BV combined treatment group; BV monotherapy group

Sintilimab DRUG

200mg/3w

Also known as: TYVYT

BV combined treatment group

Tislelizumab DRUG

200mg/3w

Also known as: TEVIMBRA

BV combined treatment group

Bendamustine DRUG

90mg/m2/3w

BV combined treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically, classical hodgkin lymphoma（cHL） was diagnosed and relapsed or refractory.
• Patients were treated with BV-containing regimen at least once
• Presence of tumor (measurable or nonmeasurable).
• Signature of the form consent for participation in the study.

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• Xiuhua Sun: lead

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Interventions

Brentuximab Vedotin; sintilimab; tislelizumab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

XIUHUA SUN

CONTACT

86-0411-84671291; 3038668@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Lymphoma and Head and Neck Oncology

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: January 7, 2025
• Study Start: December 31, 2024
• Primary Completion: December 17, 2025
• Study Completion: January 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share